Se­nate bill lets dy­ing pa­tients take medicines in trial stage

Ex­tends FDA’s abil­ity to charge fees, funds agency

The Washington Times Daily - - POLITICS - BY TOM HOW­ELL JR.

The Se­nate unan­i­mously ap­proved bills Thurs­day that would let dy­ing pa­tients try medicines that haven’t won full reg­u­la­tory approval and in­form doc­tors if a pa­tient is a re­cov­er­ing drug ad­dict, so they can pre­scribe safe treat­ment.

Both mea­sures passed be­fore the Se­nate voted over­whelm­ingly to ex­tend the Food and Drug Ad­min­is­tra­tion’s abil­ity to charge fees on com­pa­nies that sub­mit their prod­ucts for pre-mar­ket re­view.

Taken to­gether, the bills of­fered a bi­par­ti­san re­set on health leg­is­la­tion af­ter a bruis­ing de­bate over Oba­macare that stalled out last week when Repub­li­cans couldn’t muster enough troops to pass their bill through the Se­nate.

The FDA fee bill was con­sid­ered must-pass leg­is­la­tion, with Congress fac­ing an end-of-Septem­ber dead­line to re­new four user agree­ments with in­dus­try play­ers, who will pay fees to­tal­ing $8 bil­lion to $9 bil­lion over five years — more than a quar­ter of the agency’s fund­ing.

Be­yond user fees, the bill also di­rect com­pa­nies de­vel­op­ing can­cer drugs for adults to look at whether their medicines could also help chil­dren, since there is lit­tle mar­ket in­cen­tive for drug­mak­ers to fo­cus on the com­par­a­tively small co­hort of younger pa­tients. It also will make cer­tain kinds of hear­ing aids avail­able over-the-counter to peo­ple with mild to mod­er­ate hear­ing loss.

The House acted ear­lier this year, clear­ing the way for Thurs­day’s 94-1 Se­nate vote to ex­tend user agree­ments through fis­cal 2022.

“It’s proof that we can make progress when we work to­gether on ar­eas where we can find agree­ment,” said Sen. Su­san Collins, Maine Repub­li­can who faulted GOP lead­er­ship’s par­ti­san push on Oba­macare and re­jected re­peal ef­forts.

Sen. Bernard San­ders, Ver­mont in­de­pen­dent, re­jected the FDA reau­tho­riza­tion bill be­cause “it does noth­ing to lower drug prices and is a give­away to the phar­ma­ceu­ti­cal in­dus­try,” said spokesman Josh Miller-Lewis.

Ear­lier Thurs­day, the Se­nate by unan­i­mous con­sent passed a bill that would let ter­mi­nally ill pa­tients who’ve ex­hausted other treat­ment op­tions ob­tain drugs that made it through first-phase safety test­ing at the FDA — though not the full approval process — with­out fear­ing in­ter­fer­ence from the fed­eral gov­ern­ment.

The Trump ad­min­is­tra­tion and other sup­port­ers say it is a com­pas­sion­ate op­tion, though op­po­nents see it is an at­tempt to weaken the FDA, since the agency has an “ex­panded-ac­cess” pro­gram for sim­i­larly sit­u­ated pa­tients and ap­proves al­most all re­quests.

Drug com­pa­nies wouldn’t be required to pro­vide the ex­per­i­men­tal drugs to pa­tients, though if they chose to, they would no longer need the FDA to sign off on it. Man­u­fac­tur­ers and doc­tors would not face ad­di­tional li­a­bil­ity if the drug doesn’t work as hoped, and out­comes couldn’t be used to de­lay or ad­versely af­fect the nor­mal re­view process.

The bill’s lead spon­sors — Sens. Ron John­son, Wis­con­sin Repub­li­can, and Joe Don­nelly, In­di­ana Demo­crat — urged House law­mak­ers to take up the mea­sure when they re­turn to work in Septem­ber.

“The Se­nate took a strong stand in sup­port of the mil­lions of Amer­i­cans and their fam­i­lies suf­fer­ing from ter­mi­nal ill­nesses,” Mr. John­son said. “Pa­tients with ter­mi­nal dis­eases ought to have a right to ac­cess treat­ments that have demon­strated a level of safety and could po­ten­tially save their lives.”

Dozens of states have their own right-to-try laws. Vice Pres­i­dent Mike Pence, a lead­ing cham­pion for the ef­fort, signed a ver­sion of the law as gov­er­nor of In­di­ana in 2015.

The Se­nate also ap­proved a bill, known as “Jessie’s Law,” that would en­sure that doc­tors have ac­cess to a con­sent­ing pa­tient’s record of drug ad­dic­tion, be­fore pre­scrib­ing treat­ment. It or­ders the Health and Hu­man Ser­vices Depart­ment to come up with best prac­tices for hos­pi­tals and physi­cians to share the in­for­ma­tion.

The bill was named for Jessie Grubb, a West Virginia na­tive who died from opi­oid over­dose fol­low­ing surgery in Michi­gan for a run­ning-re­lated in­jury.

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